10 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INJEKT SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
VARIANT II TOTAL GHB
FDA 510(k)
FDA Class 2
·Hematology
STERILOX LIQUID CHEMICAL STERILANT SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
iCOR
FDA UDI
TELEFLEX INCORPORATED·09555342304008·Fha
DEXCOM ONE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 17, 2025
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 27, 2013
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·March 22, 2011
EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code KRH·June 19, 2008
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015